Validation Codex Alimentarius Commission

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

CX/MAS 02/12 (2002), Codex Alimentarius Commission, Codex Committee on Methods of Analysis and Sampling (FAO/WHO), Validation of methods through the use of results from proficiency testing schemes, agenda item 8c of the 24th session, Budapest, Hungary, Nov. 18-22, 2002. 

Use of methods validated according to criteria specified by the Codex Alimentarius Commission... 

There are two sources of information from the CAC that provide guidance on the validation of analytical methods. General guidance on method validation, including single-laboratory method validation, may be found in the CAC Procedural Manual.This is supplemented by Codex Alimentarius Commission guidelines, a number of which have been adopted from harmonized guidelines previously developed by independent international scientific... 

The subsequent lUPAC/ISO/AOAC Symposium on Single Laboratory Validation, held in Budapest, November 4-5, 1999, resulted in the draft working paper that, after international review and comment, was adopted as a harmonized guideline and published by lUPAC in 2002. This lUPAC guideline has also been adopted as a guideline by the Codex Alimentarius Commission. ... 

The current list of performance characterishcs or related factors (discussed in greater detail in Sechon 8.7) to be considered in planning a method validation according to recom-mendahons from the Codex Alimentarius Commission includes ... 

Analytical results for the determination of antibiotic residues in food, in common with results generated in other laboratories or branches of analytical chemistry, must be reliable and comparable. It is a requirement for laboratories accredited under the ISO/IEC 17025 quality system that the measurement uncertainty associated with a result should be made available and reported if it is required by the client, is relevant to the validity of the test results, or may affect compliance with a specification, for example, compliance with a maximum residue limit (MRL) for antibiotics. The Codex Alimentarius Commission also recommends that laboratories provide their customers on request with information on the measurement uncertainty or a statement of confidence associated with quantitative results for veterinary drug residues. The relevant sections in ISO 17025 are quoted below ... 

When proposing an MRL, the Rapporteur Member State (RMS) identifies the Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) for man that is valid for the pesticide in question. The ADI thus identified is often the same as that recommended by the Joint FAO/WHO Meetings on Pesticide Residues (JMPR), whose recommendations on ADIs and MRLs are used within the Codex Alimentarius system. If the ADI proposed by the RMS is not that recommended by JMPR, the RMS has to provide an explanation for the difference. The other Member States comment on the RMS proposal at meetings of the Working Group on Pesticide Residues. If the Member States cannot reach agreement on the evaluation, the matter is referred to one or more of the Commission s scientific advisory committees. Prior to autumn 1997, such questions were referred to the Scientific Committee for Pesticides, but since then they have been referred to the Scientific Committee on Plants. 

Criteria for quality and genuineness of the various olive oil types are described in the Norm of the Codex Alimentarius (1993) and EU Commission Regulation 2568/91 and its amendments. An important amendment of the basic regulation is Reg 2472, which summarises most of the changes since 1991 and is valid from February 1998 (European Commission 1997). 

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